In the latest 2022 report curated by Data Bridge Market Research , the global cleanroom technology market is anticipated to grow to USD4.25bn by 2029 .
The choice of moulding machinery selected for cleanrooms is generally customerspecific . Where medical components need to be manufactured and packed in a selfcontained cleanroom environment to meet ISO Class 7 or 8 standards and comply with any GMP Annex 1 and FDA regulations , a fully configured all-electric injection moulding machine can be a straightforward way to eliminate the biggest contamination risks … people .
That ’ s because the exposed points where a plastic component may come into contact with the environment are all enclosed . For that very reason , virtually every global cleanroom project undertaken by the medical team at Sumitomo ( SHI ) Demag now features an IntElect machine .
KEEPING IT SIMPLE
Andrew Sargisson stresses the need for organisations to keep things simple when it comes to commissioning moulding machinery for a cleanroom environment and cautions against over specifying superfluous equipment . This , he claims , is likely to create needless issues down the line .
For example , focussing solely upon the cleanroom classification itself could leave medical manufacturers exposed to unwarranted compliance requirements that , once approved , they must continue to adhere to . Sometimes effective ventilation is all that ’ s required . Yet , for sterile medicinal products , the requirements - defined by Annex 1 of the EU and PIC / S GMPs – are now even more stringent .
This is where global expertise is a true benefit . Out of regulatory fear , people may submit a user requirement specification ( URS ) request for a cleanroom solution that is excessive for the medical component being made . cleanroom project . This makes it much easier to manage defined steps for design , installation , operational and production Qualifications and Validations of cleanroom machinery .
Turning Cleanrooms into ‘ Greenrooms ’ As filtered air controlled production environments , moulding cleanrooms are extremely energy intensive . Experts estimate that in some cleanroom facilities , the air units that circulate fresh air and extract particulates can consume around 60 percent of all production power .
Given today ’ s energy crisis , there ’ s a real push to conserve natural resources and reduce the ecological impact . Yet , stringent workflows to prevent pollutants spreading and contaminating products make this inherently challenging in cleanrooms .
To counter any adverse impacts of the ensuing energy crisis , medical moulders may want to consider fully utilising any ‘ white space ’ inside their cleanrooms , occupying any extra space with additional machinery or equipment . The benefits of this are multiple , in that organisations can increase their operational capacity without the need to power or fuel additional space .
Lower ceiling heights is another tactic to reduce the overall atmosphere that requires HEPA filter control . Even if the physical space remains unchanged , the reduced footprint of today ’ s compact allelectric machines now enables MedTech manufacturers to optimise their cleanroom envelope , boosting cost and productivity metrics considerably .
Clamping down on heat generation Over-cluttering is not in-line with the GMP standards . Removing free-standing periphery equipment from the floor and integrating into the moulding machine cell , including hot runner controllers , cables , and even automation , eliminates another surface area and consequently additional sources of heat generation .
Integrated electric direct drives is another consideration . Providing the force transmission , one of the key processing advantages of electric drives is the ability to control the linear axis with velocities in excess of 500mm / s . With no belts spinning , the drives don ’ t have to work as hard .
This increased efficiency gained from direct drives means that they use considerably less energy – in the case of the IntElect between 40 % and 85 % less than conventional solutions .
Having this level of drive control also makes a subtle difference to clamp force . Use too much force and the machine ’ s energy consumption rises . Rather than diverting straight to the maximum clamp force , a medical IntElect machine , with its smaller than average injection unit , can override and select the appropriate clamp force for a particular combination of component geometry and polymer material . For high cavitation medical components , where precision is fundamental , this is a gamechanger , as the machine isn ’ t overworking itself . When this happens not only is excess heat being generated , it can also cause premature tooling wear and tear .
Heat transference is another consideration . A portion of electrical power is used to directly heat the barrel to melt resin . Another to run the machine drive , inverters and motors , which in turn also generates heat . All of the heat generated must be dispersed either via thermal convection or – in most cases – an active cooling system .
Thermal imaging of the direct drive provides a good indicator of any inefficiencies and heat emissions . On the IntElect machines , the active air cooling ( fan ) is not activated until the motor reaches 55 ° C . If no heat emission on the drive , no additional energy is consumed .
Big moulds … small contained space In order to achieve the highest production output in the smallest space , the medical IntElect ’ s larger than average platen area offers greater production flexibility and accommodates various high cavity tool configurations .
As a global medical team that works collaboratively across borders and are all GMP-trained , the group is able to pull in technical experts and provide high quality consultancy at the start of any medical
A fully configured all-electric injection moulding machine can be a straightforward way to eliminate the biggest contamination risks … people
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